MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problem Mechanics Altered (2984)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Event Description

It was reported that during a navio tka procedure, the handpiece exposure control motor failure warning appeared while beginning the femur bone removal.They attempted handpiece re-assembly, and inserted a new burr.After four failed attempts to recalibrate the handpiece, they switched to manual instrumentation with a delay greater than 30 minutes.No other complications were reported.

Manufacturer Narrative

Additional information received from the investigation team.Section h6 was updated.Internal complaint reference number: (b)(4).Section b5, d1, d4 were corrected.

Event Description

It was reported that during a navio tka procedure, the handpiece exposure control motor failure warning appeared while beginning the femur bone removal.They attempted handpiece reassembly and inserted a new burr.After four failed attempts to recalibrate the handpiece, they switched to manual instrumentation with a delay greater than 30 minutes.No other complications were reported.Both the handpiece and the drill were tested without abnormalities noted.Therefore, the long attachment is likely the cause of the error.

Manufacturer Narrative

H3, h6: the device (pn 110006, sn (b)(6)), used in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the risk profile.The navio user's manual (500196) and surgical technique guide (500197) provide instructions for long attachment setup with the handpiece and drill, as well as troubleshooting for common error messages.We were not able to confirm if there was a relationship established between the reported event and the device.No issues were identified visually and the long attachment passed all tests in functional evaluation.There was no problem found with the device.A factor that could have led to the reported issue is not a long attachment issue, but based on the case screenshots it is possible that each time the handpiece was calibrated and homed during cutting, the point probe was left on the handpiece when re-entering cut mode, causing the reported handpiece exposure motor control error.Without the case log files or handpiece, we cannot confirm this.Based on the investigation, no corrections or corrective actions required at this time.The medical investigation found that per complaint details, the device malfunctioned at the beginning of femoral bone removal and did not resolve after multiple troubleshooting attempts; therefore, the navio procedure was abandoned and a manual procedure was used to proceed with the case.The provided screenshots support the complaint; however, per the field report, the handpiece and drill were tested with no abnormalities.The reported long attachment pv failure ¿was not confirmed¿ per the functional product evaluation.No patient injury/impact was reported.Responses to the requested clinical documentation was not provided.The patient impact beyond the modified surgical procedure and the reported >30-minute surgical delay could not be determined, although no patient injury was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.

• Brand Name: NAVIO LONG ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10805154
• MDR Text Key: 215282421
• Report Number: 3010266064-2020-01965
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 05/14/2021; 05/18/2021
• Supplement Dates FDA Received: 05/14/2021; 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAVIO LONG ATTACHMENT, NAVIO SURGICAL SYSTEM US
• Patient Outcome(s): Required Intervention